How will you make an impact?
You will be responsible for evaluation of existing manufacturing processes and methods, resolving manufacturing process challenges, and maintaining effective and efficient processes in the manufacturing of culture media.
What will you do?
Be the prime for evaluating, establishing, improving, and qualifying manufacturing processes following GMP and Thermo Fisher Scientific’s guidelines by understanding product requirements and applying knowledge of product, manufacture, equipment and materials.
Collaborate with Quality Engineering to review non-conforming processes. Identify trends, investigate, propose solutions, and track results.
Lead investigations on product failures with RCCM and quality control metrics
Identify and execute special projects that will bring cost savings through Practical Process Improvements (PPI) programs.
Drive PPI projects in manufacturing through Six Sigma and Lean manufacturing techniques.
Develop and improve processing parameters (sterilization, dispensing and packaging) for optimal process performance by using creative and unrivaled thinking.
Provide manufacturing decision-making information and communicate production status, deviations, issues and general information to manufacturing management.
Resolve critical issues without affecting productivity. Utilization of good judgment on demonstrating short term impact versus long term goals.
Bring familiarity with use of statistical and data analysis methodologies.
Facilitate the acquisition of all data from process orders or data acquisition (DA) equipment. Utilize your knowledge in Statistical Process Control (SPC) and other statistical tools.
Develop and update manufacturing work instructions, job-aids, and assist in implementing approved changes.
Assist quality engineering in resolving customer complaints through targeted projects and CAPA processes.
Review product formulations using batch records, technical manuals, and applicable publications to identify formulation discrepancies.
Initiate process variances to the identified nonconforming products in order to ensure identified problems are corrected immediately.
Initiate device change requests to products and standard operating procedures to resolve nonconformities based on the documented root cause analysis.
Conduct training and provide mentorship for Production personnel on new processes or process changes
Additional duties as needed.
How will you get here?
B.S. in Mechanical, Electrical, Industrial Engineering or related field.
2-5 years technical experience that includes process engineering, process development, project management.
Knowledge of GMP, experience in ISO 13485 environment is considered an asset.
Six Sigma or Lean manufacturing experience is an asset.
Ability to plan and lead multiple tasks and/or projects
Good analytical skills, problem-solving techniques, and data handling skills using Excel
Excellent communication skills, both written and verbal
Excellent reciprocal skills, working with department supervisors and other departments using verbal and written communication to resolve product and process problems.
Capital projects involvement/implementation experience
Preferred experience within the medical device or pharmaceutical industry.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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